Study of the Effects of Pomegranate Tablets on Enlarged Prostates

Status Unknown status

Clinical Trial Summary

To determine whether pomegranate tablets have a therapeutic effect on Benign Prostatic Hyperplasia.

Clinical Trial Description

Patients with newly diagnosed benign prostatic hyperplasia (BPH) will be recruited from the urology clinic at UCI medical center for this study as indicated in section 4. Once recruited, patients will be randomized into two groups - placebo and pomegranate tablets.

Prior to randomization, there will be a 6 week run-in period in which the basal parameters will be established. The basal parameters include a complete history and physical exam including an AUA symptom questionnaire and men's sexual health questionnaire, urine culture, urinalysis, PSA, serum chemistry (sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose), serum free testosterone, serum dihydrotestosterone, maximum urinary flow rate (Qmax), post void residual bladder volume, and prostate volume measurement via Trans-rectal ultrasound. Then patients will be randomized either to the study group or to the control group using a random number generator. All of the study subjects will be counseled to take one capsule daily in the morning and not to consume any other prostate supplements, or other forms of medical or herbal therapy for BPH.

Patients will be asked to come in every 2 months for the following tests and questionnaires to be administered:

1. AUA Symptoms Score sheet

2. Men's Sexual Health Questionnaire

3. Urine culture

4. Urinalysis

5. PSA

6. Serum chemistry (sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose)

7. Serum free testosterone

8. Serum 5-dihydrotestosterone

9. Maximum urinary flow rate (Qmax)

10. Post void residual check

11. Prostate volume measurement via Trans-rectal ultrasound

Maximum blood volume that will be drawn for each blood draw is 10 ml (2 table spoon), and the maximum blood draws per patient is 3 per person if there is no crossover and 6 if there is a crossover. Prior to all blood draw, patients will be asked to refrain from sexual intercourse for at least 48 hrs.

Patients with severe BPH (AUA symptom score 20 and above) or those already on other forms of medical therapy such as prescription finasteride, terazosin, or tamsulosin, propecia (for hair loss) or have any history of prostate surgery are not eligible to participate in this study. Also, patients who are taking non prescription supplements such as Saw Palmetto, B-sitosterol, vitamin E, quercetin, will not be included in the study. One group (n = 10) will take the pomegranate tablet. Group 2 (n = 10) will take 1 placebo tablet in the morning daily. Both pomegranate tablets and placebo will be provided by the Pomegranate Health Company.

Prior to randomization, there will be a 6-week run-in time because voiding parameters are notoriously variable. During this run-in time, patients will be asked to return to clinic every two weeks to measure maximum urinary flow and post-void residual bladder volume.

After a six-month period, each subject will be crossed over individually from placebo to active treatment, and from active treatment to placebo. The total anticipated timeline for the study is 12 months.

If early termination from the study is requested a final evaluation will be given. The final evaluation of the study will entail a standard office visit with blood collection and final AUA symptoms score and Men's sexual health questionnaire, and a transrectal ultrasound of the prostate measuring the same parameters as in the previous office visits. Subsequently, recommendations will be made by a urologist regarding the standard treatment options for BPH. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00381108
Study type	Interventional
Source	University of California, Irvine
Contact
Status	Unknown status
Phase	Phase 1
Start date	September 2005
Completion date	June 2010

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04807296` - Thulium Fiber Laser Enucleation of the Prostate (TFLEP) vs HoLEP With Moses Technology (m-HoLEP)	N/A
Recruiting	`NCT05574244` - Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction	N/A
Recruiting	`NCT04288427` - 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy	N/A
Not yet recruiting	`NCT04245566` - Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH	Phase 3
Withdrawn	`NCT01967251` - Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction	Phase 2
Completed	`NCT03246880` - Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients	Phase 3
Completed	`NCT02509975` - Safety and Efficacy of OCL 503 in Prostate Artery Embolization	N/A
Completed	`NCT02283684` - GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT	Phase 4
Completed	`NCT02206243` - Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
Completed	`NCT01454349` - Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)	Phase 1/Phase 2
Completed	`NCT01438775` - Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)	Phase 3
Completed	`NCT01152190` - A Study in Benign Prostatic Hyperplasia	Phase 3
Completed	`NCT01139762` - A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms	Phase 3
Active, not recruiting	`NCT00400894` - Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma	N/A
Completed	`NCT00224133` - The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months	Phase 3
Completed	`NCT00701779` - Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia	Phase 4
Terminated	`NCT02962674` - To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.	N/A
Active, not recruiting	`NCT05415748` - Deprescribing Tamsulosin in Older Men	Phase 4
Recruiting	`NCT04853914` - Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.	N/A
Completed	`NCT04831476` - Α Prospective Observational Study for the Evaluation of Disease Control and Quality of Life in Patients With Benign PROStatic hyPERplasia Under Fixed Dose combΙnaTion Treatment With Dutasteride and Tamsulosin . PROSPERITY Group of Studies (I&II)